The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Encor 7 Gauge.
| Device ID | K051158 |
| 510k Number | K051158 |
| Device Name: | ENCOR 7 GAUGE |
| Classification | Instrument, Biopsy |
| Applicant | SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo, CA 92656 |
| Contact | Amy Boucly |
| Correspondent | Amy Boucly SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo, CA 92656 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-05 |
| Decision Date | 2005-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741086325 | K051158 | 000 |
| 10801741086295 | K051158 | 000 |
| 10801741086288 | K051158 | 000 |
| 10801741086271 | K051158 | 000 |
| 10801741086264 | K051158 | 000 |